Vaginal medicator

ABSTRACT

A vaginal medicator adapted to be retained within the human vaginal canal to apply medication molded thereon to the vaginal canal and cervix including body-undissolvable stem and anchor means. The stem is formed into various shapes and lengths, each designed to reach along the length of the vaginal canal from its lower end to the region of the cervix thus enabling medication molded thereto to be delivered where desired within the vaginal canal. The stem may include loops, webs and meshes for carrying additional medicaments and for increasing the application of medicaments to the cervix. The anchoring means may be a spherical, ellipsoidal or cylindrical mass connected at one end of the stem adapted to hold the medicator in proper position by virtue of the constricting muscles at the entrance to the vaginal canal. Alternatively, the structure of the stem itself, such as a substantially triangular looped stem or a stem having a cervix surrounding loop at its inner end may adequately serve as the anchoring means.

Groves United States Patent 191 [4 June 11, 1974 [541 VAGINAL MEDICATOR[76] Inventor: Harvey 11. Groves, 6 Cherry Ln.,

Westport, Conn. 06880 [22] Filed: July 24, 1972 [21] Appl. No.: 274,263

[52] US. Cl 128/271 128/270, 128/285 [51] Int. Cl A611 13/20, A61m 31/00[58] Field of Search 128/232, 270 X, 271, 285 X [56] References CitedUNITED STATES PATENTS 1,915,176 6/1933- Yamaguchi 128/271 2,884,9255/1959 Meynier, Jr 128/270 3,054,403 9/1962 Baker 128/270 x 3,102,540/1963 Bentov 128/285 X 3,570,489 3/1971 Brown 128/271 PrimaryExaminer-Aldrich F. Medbery Attorney, Agent, or Firm-Wooster, Davis &Cifelli [57] ABSTRACT A vaginal medicator adapted to be retained withinthe human vaginal canal to apply medication molded thereon to thevaginal canal and cervix including body-undissolvable stem and anchormeans. The stem is formed into various shapes and lengths, each designedto reach along the length of the vaginal canal from its lower end to theregion of the cervix thus enabling medication molded thereto to bedelivered where desired within the vaginal canal. The stem may includeloops, webs and meshes for carrying additional medicaments and forincreasing the application of medicaments to the cervix. The anchoringmeans may be a spherical, ellipsoidal or cylindrical mass connected atone end of the stem adapted to hold the medicator in proper position byvirtue of the constricting muscles at the entrance to the vaginal'canal.Alternatively, the structure of the stem itself, such as a substantiallytriangular looped stem or a stem having a cervix surroundingloop at itsinner end may adequately serve as the anchoring means.

14 Claims, 15 Drawing Figures PATENTEBJUNH 1914 3.815600 sum 1 OF 2 v I1 ,VAGINAL MEDICATOR BACKGROUND OF THE INVENTION The present inventionrelates to medicators and, more particularly, to vaginal medicators orsuppositories. One of the principal requirements .for applying topicalmedication to the body is that the medication remain in the desired bodyarea for an extended period of time. For example, in the'treatment ofvaginal disease, itis desirable that the medication be applied for manyhours to remote regions of the vaginal canal and cervix. These regionsare not readily reached by conventional vaginal suppositories due totheir size and shape. Due to the structure and nature of thehumanvigina, for example, inserted suppositories or ovules often do not stayin place, or upon melting, the medicato provide a vaginal medicatorwhich .can deliver medication to the entire vaginal canal and the cervixor any portion thereof for extended periods of time.

It is another object of the present invention to provide a vaginalmedicator which may be comfortably retained within the vaginal canal forextended periods of time.

It is still another object of the present invention to provide a vaginalmedicator which may be maintained in a desired position within thevaginal canal.

tion may drain out of the vagina, substantially reducing itseffectiveness. In either of these cases, the medication is notmaintained in the desired location for a sufficient duration of time,nor does it necessarily find its way to affected parts in thevaginalcanal which are remote fromthe normal positioning ofsuppositories.

Prior attempts at overcoming these problemsjhave not been satisfactory.For example, presently available medicated cotton tamponsdo not extendalong the length of the vaginal canal and, therefore, cannot delivermedication where desired. Furthermore, they do not allow for-efficienttransfer of medication to affected areas, nor can they be used to applymedication to selected areas because of the highly absorbent na- It is afurther object of the present invention to'provide a vaginal medicatorwhich provides for efficient transfer of medication to the affectedareas.

BRIEF DESCRIPTION OF THE DRAWINGS drawingsin which:

ture of the cotton fibers. Other medicators are uncomfortable to insertand use because of their rigid structure.

SUMMARY OF THE INVENTION These problems and disadvantages are overcomeby the present invention by providing a medicator which extends alongthe entire length of the vaginal canal to the cervix so that medicationmay be delivered wheris molded to the stem. The medicator is held inplace by virtue of the action of the constricting muscles at the lowerregion of the vaginal canal and the anchoring means of the medicator.The anchoring means may be provided by a mass of body-undissolvableplasticor other suitable material secured to one end of the stem.

' FIGS. la-b are illustrations of a first embodiment of the presentinvention without and with medication. applied, respectively.

' FIG. 2 is an illustration of a modified version thereof with acylindrical anchor.

vFIG. 3 isan illustration of another modified version thereof with ahollow drug-permeable stem-and anchor.

FIG. 4 is an illustration thereof with additional medication provided'atthe inner end thereof and along the .ever desired and which providesefficient transfer of medication and is comfortable to use. Morespecifi- This mass, which is preferably spherical, ellipsoidal or stemin relation to the anatomy of the vaginal tract.'

Such configurations include loops to encircle or partially surround thecervix, cup-shaped webs attached to the stem and designed to fit overthe cervix and the generally triangular shape of the looped stern whichresolves the lateral forces from the constricting muscles and thenaturally collapsing walls of the vagina into lonpullout string.

FIG. 5 is an illustration of a modified version thereof in which asecond body-undissolvable bulb is included at the inner end.

FIG. 6 is an illustration of a modified version thereof in which thestem includes a laterally extended web or mesh to increase the surfacearea and amountof medication.

FIGS. 7a-e are illustrations of various modified versions of a secondembodiment of the present invention in which the stemis formed in asubstantially triangular configuration with a cervix engaging loop.

FIG. 8 is an illustration of a modified version of the FIG. 7amedicatorjn which a mesh extends within the area enclosed by thestem toincrease the surface area and amount of medication.

FIGS. 9a-b are illustrations of two versions of a third embodiment ofthe present invention in which theinner end of the stem terminates in acervix engaging loop and cup, respectively.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Three embodiments ofthe present invention will now be described, as well as variousmodifications which may be incorporated in each. Although some of themodifications are described in conjunction with only one embodiment, itwill readily be apparent that many of them may be incorporated in otherembodiments as well.

embodiment-of the vaginal medicator, generallydesignated 10, will bedescribed. The medicator includes a'ilexible or semirigid stem 12 formedfrom a body-.

undissolvable' plastic material, a fiber thread, or other suitablematerial. The stem 12 is secured to an anchor 14 which may be formedfrom cotton, fibrous material, plastic or other suitable material. Apullout string 16 is attached to the anchor 14 for purposes of manuallyremoving the device after use. This pullout string 16 may be separatelyattached to the anchor 14 or may be an integral extension of the stem12. v

' The anchor 14 is preferably either spherical (14) as shown. in FIGS.la and 1b, cylindrical (14') as shown in FIG. 2 or ellipsoidal (notshown). If the anchor 14 is to be made of cotton it may be formed byspinning cotton onto the end of the stem 12; and may be bound to itselfthrough impregnation of the cotton with waxes,

resins, sizing compounds, latexes, etc., and subsequently coated with aresin or other materials similar to those indicatedabove to provide anonabsorbentsurface, or partially absorbent surface as may be desired.The anchor 14 may also be fastened to the stem by using bonding cementor by heat-plasticising the end of the stem 12. The anchor 14 also maybe formed by means other than by spinning, for example by sewingtogether cotton wads and subsequently attaching them to the stem.Alternatively, the anchor can take the form of aconventional tampon ofshortened length and sewn or otherwise secured to the end of the stem12. If the anchor 14 is cotton,'it may be designed to expand afterinsertion while also increasing its absorbency, if so desired, by notapplying sizing, bonding, or coating compounds and/or by containing thenaturally expansive fibers within a hollow applicator similar to thatused to A medication 22 shown in partial cross section surrounding'thestem 12 in FIGS. 15,2 and 4 may contain medicaments, drugs, etc.designed for local and/or sysT temic effects, which may or may not beabsorbed by the vaginal mucosa, suspended in a pharmaceutical basedesigned to melt slowly over a period of hours as a result of thetemperature of the body or .to dissolve slowly as a result of contactwith body fluids. Examples of suitable pharmaceutical bases includepolyethylene glycols, glycerogelatins, gelatins, waxes, modified fatsand fatty oils. The cros's-sectional-diameter of the stem 12 andsurrounding medication 22 may be approximately 1/4 inch to 3/8 inch andis considerably less than the diameter of the anchor 14. If desired, anincreased amount of the medication 22 may be formed at or adjacent theblunt end 18 of the stem 12, such as at 24 (FIG. 4). This provides anincreased amount'of medication to the cervix and upper portion of thevaginal canal. Additionally, the medication 26. may also be providedaround the pullout string 16 to deliver medication to the extreme lowerportion of the vaginal canal.

insert conventional'vaginal tampon s, so that expansion takes placeafter insertion of the deviceand subsequent removal of the applicator.If the anchor 14 is plastic, it may be attached to the. stem 12 bycement or by means of heat, sonic, or high frequency welding or othermethods. In addition to the modes of attachment previously described thestem 12 and anchor 14 may also be formed from a unitary, continuouspiece of plastic such as by injection molding.

The inner end of the stem, that is the end remote from the anchor 14'may be provided with a blunt end 18 by spinning-a small amount of cottonor other fiber to guard against possible abrasion of body tissues afterthe'medication has been dissolved away. The blunt end 18 may also beprovided by dip-coating the inner end of the stem 12 into plastic meltsor by bonding a premolded bulb of body-undissolvable material such asplastic to the end of the stem 12. This bulb may be a small blunt tip 18or a somewhat larger bulb 20 as shown in FIG. 5.

The anchor 14 and the stem 12 may vary in size depending upon the sizeof the human in which. they are to be used. The stem must be longenough' to reach to the upper most extremities of the vaginal canal tothe region of the anterior or posterior fornices when the anchor isinposition in the lower part of the vaginal canal in the same generalregion occupied by conventional vaginal tampons. For the typical adulthuman, the stem may be approximately H332 to l=/l6 inch in diameter and3 to 4 inches in length, and the anchormay be approximately 3/4- inch indiameter.

The embodiment of the vaginal medicator 10 as thus far described mayalso be modified by making either or both the anchor 14 and the enlargedbulb 20 hollow and drug-permeable so that additional medication mayenlarged bulb 20 whether hollow and containing medication or not givesadditional anchoring to the suppository by-being located in the vaultofthe vagina near the cervix. It also may be used to provide additionalmedication to the area near the cervix by being drugpermeable andcontaining medication or by surrounding a solid bulb with medication.

In the same manner, the entire medicator 10 may be hollow and formedfrom a drug-permeable material as shown in FIG. 3. The stem 12 isintegral with the anchor 14" to form a continuous hollow core which maybe filled with medication. In this arrangement the stem 12 will .beapproximately the same dimensions as the stem 12 with medication 22thereon.

This embodiment of the vaginal medicator 10 may be modified as shown inFIG. 6 to include a mesh or web '30 to which medication may be adhered.Although, as

- shown, the web 30 extends along the entire length of the stem 12 itshould be understood that the web 30 could be designed to extend alongonly a portion of the stem 12 or, alternatively, could comprise aplurality of individual portions. The addition of the web 30 allows themedicator 10 to carry additional medication and provides a greatersurface area of medication if desired. The mesh or web 30 may be formedfrom flexible plas tic netting, fabric mesh, polymeric film or othersuitable material, and may be attached to the stem 12 by any suitablemethod, such as welding, cementing or stitching.

Now with particular reference to FIGS. 7a-e and 8 a second embodiment ofthe presentinvention will be described. In this embodiment, the vaginalmedicator generally designated 32,

includes a looped stem 34 I connected to an anchor 36 which may beidentical to 6. As in the first embodiment, a pullout string 38 is alsoprovided. The looped stem 34 is dimensioned so as -to reach theposterior fornix of the vaginaand surround the cervix. As in the firstembodiment, slow dissolving medication 40 surrounds the stem 34. In thisembodiment the looped stem 34 seats behind the cervix, and thesubstantially triangular shape of the loop resolves lateral forces fromthe surrounding musculature of the vagina into longitudinal forces alongthe longitudinal axis of the medicator 32 urging it'upwards into thevagina. Because these features serve to anchor the medicator 32, thedistinct anchor 36 may be omitted as shown in FIG. 7b without impairingthe utilization of the medicator-.32. In such a modification the pulloutstring 38 is connected directly to the stem 34 as shown at 42. Othermodifications may also be made-in the medicator 32. For example, asshown in FIGS. 70 and 7d the inner-end of the stem 32 may beformed intoa 6 purposes may be administered along the entire length of the vaginalcanal or any portion thereof.-

Once inserted the medication slowly dissolves either by virtue of bodytemperature or body fluids. As described in detail previously, variousmodifications may. be made to increase .the amount or surface ofmedication to a desired area. For example, additional medication 24 or adrug-permeable bulb may be included at the inner end of the stem l2'o fthe first embodiment. Furthermore, where increased delivery ofmedication is desired in the cervix area the embodiment of FIGS.

circular loop by including an extra portion 44 or by being necked in asat 46, respectively, to allow medication to completely surround thecervix. The stem 34 may also be formed as a hollow drug-permeable member34', as shown in FIG. 7e, similar to the modification of the firstembodiment illustrated in FIG. 3. The anchor 36 may also be hollow anddrug-permeable, and may forma continuous core with the stem 34. Finally,a web or mesh 48 (FIG. 8) may be extended within the area enclosed bythe stem to allow the medicator to carry additional medication and toprovide a greater surfacearea of medication. The mesh or web 48 may bepreferably formed in a cup or concave shape so as to permit the innerend of the looped stem 34 to surround the cervix.

A third embodiment of the present invention is illustrated in FIGS.9a-b. This embodimen-t'differs from the first described embodiment onlyin that a looped end anchor the medicatorin place. Therefore, thedistinct anchor 54 may be deleted.

. Other modifications and variations will also become apparent to thoseskilled in the art. For example, any of the above embodiments ormodifications thereof may be further modified by angling, bending orcurving the stem to allow the medicator to more naturally conform to theanterior and posterior fornices of the vagina adjacent the cervix.

Each of the embodiments of the present invention and the variousmodifications thereof may easily be used. The vaginal medicator isinserted up into the vaginal canalwith the inner end of the stemreaching up into'the region of the cervix, and the anchor being seatedin and-held in place by the constricting muscles at the entrance to thevaginal canal. With this configuration, medication whetherto be forlocal or systemic 7a-e, 8 or that of FIGS. 9a-b may be utilized so thatthe cervix is surrounded by medication. Further increases in the amountand surface area of medication may be had by utilizing the mesh or webmodifications discussed previously with respect to FIGS. 6, 8 and 9b.-

' In the latter two described embodiments, the loops of the stem may becompressed for ease of in'sertio'n, and the medicator is positioned sothat the inner loop of the stem surrounds the cervix. The elastic memoryof the stems and the amorphous characteristic of the medica tion willrestore the shape of. medication and prevent cracking or shifting of themedication; All of these embodiments are easily accommodated within thevaginal canal and are as comfortable to'use or wear as an ordinarytampon. 1

Thus, an improved vaginal medicator has been provided withichsignificantly improves the application and supply of both local andsystemic medication to the vaginal canal, is easily used, and iscomfortable to wear.

one end of said stem means, said anchoring mass being of a size to beretained above-the constricting muscles at the entrance to the vaginalcanal with at least a portion'of the stem means extending upwardly fromsaid anchoring mass to be positioned in the upper portion of the vaginalcanal and near the cervix; medication carried by said stem means forslowly dissolving in the vaginal canal to supply medication thereto; andpullout means connected to said anchoring mass and extending out fromthe vaginal canal when the medicator is in place therein for providingeasy removal of the medicator. 2. The medicator of claim 1 wherein saidanchoring mass is spherical.

3. The medicator of claim 1 wherein said anchoring mass is cylindrical.

4. The medicator of claim 1 wherein said anchoring mass is formed fromcotton.

5. The medicator of claim 1 wherein said anchoring mass is formed fromplastic.

6. The medicator of claim 1 wherein said anchoring mass is hollow, isformed from a drug-permeable material and contains medication thereinwhich is slowly released to the vaginal canal.

7. The medicator of claim 6 wherein said stern means is a hollowtube-like member formed from a drugpermeable material, said hollowmember opening. to said hollow anchoring mass to form a continuous corethrough the medicator.

8. The medicator of claim 1 wherein said stem means is a thin flexiblestem and said medication is in the form of a body-dissolvable moldablesolid surrounding said stem.

9. The medicator of claim 8 wherein said pullout member surrounded bysaid l l. The medicator of claim 1 wherein said elongated stem is a thinflexible stem with a blunt inner end, and said medication is in the formof a body-dissolvable moldable solid surrounding said stem and saidblunt end. a

12. The medicator of claim 11 wherein said medication is formed into anenlarged bulb around said blunt end.

13. The medicator of claim 1 wherein said stem means includes web meansextending laterally therefrom, on which medication may be adhered.

'14. The medicator of claim 1 wherein said stem means .is approximately3 to 4 inches in length.

1. A vaginal medicator comprising: elongated body-undissolvable stemmeans for extending along substantially the entire length of the vaginalcanal to the region of the cervix; a body-undissolvable anchoring massconnected to one end of said stem means, said anchoring mass being of asize to be retained above the constricting muscles at the entrance tothe vaginal canal with at least a portion of the stem means extendingupwardly from said anchoring mass to be positioned in the upper portionof the vaginal canal and near the cervix; medication carried by saidstem means for slowly dissolving in the vaginal canal to supplymedication thereto; and pullout means connected to said anchoring massand extending out from the vaginal canal when the medicator is in placetherein for providing easy removal of the medicator.
 2. The medicator ofclaim 1 wherein said anchoring mass is spherical.
 3. The medicator ofclaim 1 wherein said anchoring mass is cylindrical.
 4. The medicator ofclaim 1 wherein said anchoring mass is formed from cotton.
 5. Themedicator of claim 1 wherein said anchoring mass is formed from plastic.6. The medicator of claim 1 wherein said anchoring mass is hollow, isformed from a drug-permeable material and contains medication thereinwhich is slowly released to the vaginal canal.
 7. The medicator of claim6 wherein said stem means is a hollow tube-like member formed from adrug-permeable material, said hollow member opening to said hollowanchoring mass to form a continuous core through the medicator.
 8. Themedicator of claim 1 wherein said stem means is a thin flexible stem andsaid medication is in the form of a body-dissolvable moldable solidsurrounding said stem.
 9. The medicator of claim 8 wherein said pulloutmeans is a thin flexible member surrounded by said medication.
 10. Themedicator of claim 1 wherein said stem means is a hollow tube-likemember formed from a drug-permeable material and said medication iscarried therein.
 11. The medicator of claim 1 wherein said elongatedstem is a thin flexible stem with a blunt inner end, and said medicationis in the form of a body-dissolvable moldable solid surrounding saidstem and said blunt end.
 12. The medicator of claim 11 wherein saidmedication is formed into an enlarged bulb around said blunt end. 13.The medicator of claim 1 wherein said stem means includes web meansextending laterally therefrom, on which medication may be adhered. 14.The medicator of claim 1 wherein said stem means is approximately 3 to 4inches in length.